Canada Addresses Diversity In Clinical Trials With New Rule For Drug Filings
Executive Summary
Health Canada wants drug sponsors to start answering questions relating to disaggregated data for sex, age and race.
You may also be interested in...
Canada Wants More Agility And Alignment In Drug Regulations
The Canadian regulator has proposed several changes to current drug regulations to deliver on its modernization commitments and leverage long-standing policies and practices.
Clinical Trial Diversity: PhRMA, Academia Lay Foundation For Network Of Community-Based Sites
PhRMA is funding an initiative to establish a network of sustainable, community-based trial sites. During 18-month proof of concept phase, 10 sites will receive training, technical support and mentorship.
New EU Filings
Givinostat, Italfarmaco’s investigational treatment for Duchenne muscular dystrophy, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.